This set of documents is intended to provide an organized resource for the tools, templates, and other resources needed to conduct clinical and translational research at OHSU. Let the OCTRI Navigator know if there is anything else that would be helpful for you to see here: firstname.lastname@example.org.
General Study Start Up Information
Information about process and billing aspects for device studies
Information about OHSU's electronic health record system
Lab information and normal ranges:
As you begin to develop your grant proposal and create your clinical research protocol these resources may be useful. Be sure to give ample consideration and time to ensuring your project is feasible.
- OCTRI's Clinical Research Development Team or Design Studio
- Data and safety monitoring plan assistance - contact OCTRI's Regulatory Knowledge and Support
- Data and safety monitoring plan for OHSU's IRB
- Data and safety monitoring board training guide, provided by Tufts CTSI
- NIH Division of Human Subjects Research (DHSR) Resources on Human Subjects, Clinical Trials and Inclusion
- NIH Data Management & Sharing Policy help through the OHSU Library
- NIH Sample Data Management & Sharing Plans
- OHSU Library resources related to working with data
- Protocol feasibility checklist
- Clinical trial protocol example outline
- Clinical trial protocol example checklist
- OHSU's IRB protocol templates - open the accordion titled "Protocol Templates"
A sample of OCTRI's boiler plate template for inclusion in funding proposals can be downloaded below.
If you are submitting a funding application with specific OCTRI resources, you must request a cost estimate to include in the proposal budget. Without a cost estimate on file we cannot guarantee the resources you plan on using will be available or feasible for your project.
Please complete our Resource Request Form to submit a request for a cost estimate and letter of support.
Budgeting for a clinical research study can be a complicated high contact activity. Here we have assembled some templates, tools and links to assist in the budgeting process.
Budget development — administrative guidance on developing a budget for grants
To make the conduct of your study go a bit smoother, we have compiled a collection of information, tools and templates for your day to day activities. If you have a great tool that you would like to share please contact us.
- Study management checklist — an example of a checklist of tasks required for the management of a clinical study
- Clinical trial regulatory file checklist
- Study-specific training sign-in log — an example of an in-service document log
- Delegation of authority log
- Laboratory list/log — an example of a log to document the laboratories that will be used in a study and the contact information for each laboratory
- Specimen log — an example of a form to track the collection and distribution of study-related biological specimens
- Protocol violation documentation form — an example of a form that can be used to document protocol violations and deviations
- Research Participant Payment Options and information about ClinCard
- Image Library - request images and anonymized images
- Consent form scanning options for Research Consents - options and tools for scanning research consents into Epic.
- Emails to Participants - Using the OHSU Secure server for Emails with participants; See FAQ here
Study Subject Tracking Templates and Examples:
- Study subject schedule tracker
- Study subject screening tracker
- Comprehensive subject tracker
- Subject drug log — an example of a log to be used for a research subject to track taking their study drug
- Subject ID card template — used for subjects to know contact information and where research is being conducted
- Adverse Event (AE) tracking log example
Using Epic for Research:
- Epic For Research Sharepoint site including forms and tools
- Epic access for OHSU research staff request form (Note: Epic research class required prior to access)
- Epic access for research monitors/auditors request form - please email this to ResearchCrdHIMclbtn@ohsu.edu for more information and questions see the Health Information Management page. Once given access Auditors and Monitors can access OHSU Connect. Also visit the O2 page with information on process for Escorted Visitors.
- Care Everywhere FAQ for use guidance related to research
- Scheduling Research Patients in Epic, see Tip Sheet on the Epic for Research Bridge Site
- Acceptable use of MyChart for Research Coordinators (policy)
- Genetic Opt-Out Training and Access to the Genetic Opt-Out Database (provided after training is complete)
Clinical Trial Registration:
- Clinical trials registration (CT.gov) quality control checklist
- ClinicalTrials.gov OHSU Sharepoint for resources and information
Knight Cancer Institute
Clinical Research Policies, Procedures and Central Offices
Under the following accordions you will find a listing of policies and procedures you should be aware of when conducting clinical research at OHSU. Note that this list may not be comprehensive.
OHSU policy manual — includes research-related policies
OHSU healthcare policy database (Ellucide or MCN)— includes all healthcare-related policies